Physical ActivityNCT02338765
MoTHER Buddy Program
A study testing mHealth Physical Activity and Buddy-partnered exercise in people with Physical Activity and Obesity, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Obesity
- What is being tested?
- mHealth Physical Activity and Buddy-partnered exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically inactive,
- having at least one child aged less than 5 years,
- having at least one family member or friend who can support physical activity engagement and reside in the same community,
- having access to computer and phone, and
- overweight/obese (Body Mass Index: 23 kg/m2 or more)
Who cannot join
- Having known medical conditions that prevent regular physical activity and
- current participation in other lifestyle modification programs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: With Help From Buddies: The Impact of Social Support Using Mobile Technology on Physical Activity Among Women With Young Children
The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.
- Conditions
- Physical Activity, Obesity
- Being tested
- mHealth Physical Activity, Buddy-partnered exercise
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Physical ActivityBehavioural
Buddy-partnered exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Buddy | Experimental | Physical activity plus having a buddy Receives: Behavioral: mHealth Physical Activity; Behavioral: Buddy-partnered exercise |
| Control | Active comparator | Physical activity only Receives: Behavioral: mHealth Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily steps
Measured: weekly during study period, up to 12 weeks
Secondary outcomes (3)
Weight
Measured: Changes in weight over the 12-week study period
Waist Circumference (WC)
Measured: Changes in WC over the 12-week study period
Hip Circumference (HC)
Measured: Changes in HC over the 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, JiWon Choi, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338765
- Sponsor's protocol ID
- A123858
- Status last verified
- Jun 2016
- First submitted
- 7 Jan 2015
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With Help From Buddies: The Impact of Social Support Using Mobile Technology on Physical Activity Among Women With Young Children
- ClinicalTrials.gov ID
- NCT02338765
- Acronym / sponsor ID
- A123858
- Conditions
- Physical Activity, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buddy | Experimental | Behavioral: mHealth Physical Activity, Behavioral: Buddy-partnered exercisePhysical activity plus having a buddy |
| Control | Active comparator | Behavioral: mHealth Physical ActivityPhysical activity only |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Physically inactive,
- having at least one child aged less than 5 years,
- having at least one family member or friend who can support physical activity engagement and reside in the same community,
- having access to computer and phone, and
- overweight/obese (Body Mass Index: 23 kg/m2 or more)
Key exclusion criteria (2 listed)
- Having known medical conditions that prevent regular physical activity and
- current participation in other lifestyle modification programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Physical Activity | Behavioural | Buddy, Control |
| Buddy-partnered exercise | Behavioural | Buddy |
Primary outcome
Daily steps
Time frame: weekly during study period, up to 12 weeks
3 secondary outcomes
Weight
Time frame: Changes in weight over the 12-week study period
Waist Circumference (WC)
Time frame: Changes in WC over the 12-week study period
Hip Circumference (HC)
Time frame: Changes in HC over the 12-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Physical Activity and Buddy-partnered exercise in people with Physical Activity and Obesity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily steps (time frame: weekly during study period, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.